Kornimate/medical-research-clean huggingface dataset:
assessment of continuous positive airway pressure therapy in osa and ild

Conditions: Interstitial Lung Disease; Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate whether biomarkers of lung epithelial and endothelial injury are associated with obstructive sleep apnea (osa) and interstitial lung disease (ild).

this study is comprised of 3 aims: aim 1: determine whether the greater osa severity is associated with higher levels of serum biomarkers of aec and endothelial injury and ecm remodeling in community-dwelling adults. this is a retrospective study that will analyze biospecimens from those who participated in the mesa sleep study \[chen et al\]. aim 2: determine whether cpap use is associated with reductions in alveolar epithelial cell (aec) injury and endothelial injury, and extracellular matrix (ecm) remodeling biomarkers in adults with moderate-to-severe osa. this is a retrospective study that will analyze biospecimens from those who participated in either the heartbeat \[gottlieb et al\] and bestair \[bakker et al\] studies. revised aim 3: a) determine whether untreated osa promotes aec and endothelial injury and ecm remodeling biomarkers in adults with ild and osa compared with those without osa; b) determine prospectively whether clinically-initiated 4-week pap therapy increases markers of alveolar endothelial lung injury in osa. participants will be recruited at columbia university and be assigned cpap therapy as an intervention.

Eligibility criteria:
inclusion criteria for patients with ild: 1. ability to provide informed consent. 2. age 18 years or greater 3. diagnosis of any of the following fibrotic interstitial lung diseases as defined by ats/ers/jrs/alat guidelines and research statements and delphi surveys: * idiopathic pulmonary fibrosis * idiopathic non-specific interstitial pneumonia (nsip) with fibrosis * chronic hypersensitivity pneumonitis with fibrosis * connective tissue disease related interstitial lung disease (ctd-ild) * unclassifiable idiopathic interstitial pneumonia with fibrosis exclusion criteria for patients with ild: 1. clinically significant lung disease other than fibrotic interstitial lung disease 2. planned change to the ipf treatment during the study period 3. current cigarette smoking (past 4 weeks) 4. lower respiratory tract infection in past 60 days. (upper respiratory tract infection is not a contraindication) 5. history of life-threatening cardiac arrhythmias 6. known chronic heart failure (lvef \< 45% or echo evidence of rv dysfunction or ph) 7. chronic opiate analgesic use 8. history of sleepiness-related automobile accident within past year of enrollment 9. expected survival time in the opinion of the investigator of less than 6 months 10. history of stroke or spinal cord injury inclusion criteria for osa patients: 1. age 18 years or greater 2. clinical diagnosis of untreated osa documented by nocturnal polysomnography exclusion criteria for osa patients: 1. current treatment with cpap or oral appliance 2. identical exclusion criteria as for ild patients

Keywords: interstitial lung disease (ild) obstructive sleep apnea (osa) cpap
clot lysis: evaluating accelerated resolution of intraventricular hemorrhage phase iii

Conditions: Intraventricular Hemorrhage

Summary: the overall objective of this phase iii clinical trial is to obtain information from a population of 500 ich subjects with intraventricular hemorrhage (ivh), representative of current clinical practice and national demographics of ich regarding the benefit (or lack thereof) of ivh clot removal on subject function as measured by modified rankin scale (mrs). this application requests funding for five years to initiate a phase iii randomized clinical trial (rct) testing the benefit of clot removal for intraventricular hemorrhage. the investigators propose to compare extraventricular drainage (evd) use plus recombinant tissue plasminogen activator (rt-pa; alteplase; genentech, inc., san francisco, ca) with evd+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ich) and large intraventricular hemorrhage (ivh defined as ich \< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).


Eligibility criteria:
inclusion criteria: * age 18-80 * symptom onset less than 24 hrs prior to diagnostic ct scan * spontaneous ich less than or equal to 30 cc or primary ivh * ivh obstructing 3rd and/or 4th ventricles * ich clot stability at 6 hours or more post ivc placement * ivh clot stability at 6 hours or more post ivc placement * catheter tract bleeding stability 6 hours or more post ivc placement * evd placed per standard medical care * sbp less than 200 mmhg sustained for 6 hours prior to drug administration * able to randomize within 72 hours of diagnostic ct scan * historical rankin of 0 or 1 exclusion criteria: * suspected or untreated ruptured cerebral aneurysm, avm, or tumor * presence of a choroid plexus vascular malformation or moyamoya * clotting disorders * platelet count less than 100,000, inr greater than 1.4 * pregnancy * infratentorial hemorrhage * sah at clinical presentation * ich/ivh enlargement that cannot be stabilized in the treatment time window * ongoing internal bleeding * superficial or surface bleeding * prior enrollment in the study * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * planned or simultaneous participation (between screening and day-30) in another interventional medical investigation or clinical trial. * no subject or legal representative to give written informed consent

Keywords: intraventricular hemorrhage thrombolysis
caf with or without ctg for the treatment of single maxillary gingival recession with nccl

Conditions: Gingival Recession

Summary: this studies evaluate the efficacy of the coronally advanced flap (caf) with or without connective tissue graft (ctg) for the treatment of single maxillary recession associated to non carious cervical lesion (nccl).


Eligibility criteria:
inclusion criteria: * age ≥18 years * no systemic diseases or pregnancy. * self-reported smoking ≤ 10 cigarettes/day. * full-mouth plaque score (fmps) and full-mouth bleeding score (fmbs) ≤ 10% (measured at four sites per tooth). * presence of single rt1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity. * presence of nccl associated with recession * no history of mucogingival or periodontal surgery at experimental sites. exclusion criteria: * prosthetic crown at experimental teeth. * gingival recessions presenting minimal amount (\< 1mm) of apico-coronal keratinized tissue (kt) extension apical to recession area.

Keywords: gingival recession non-carious cervical lesion connective tissue graft
clostridioides difficile infection - a prospective nationwide epidemiologic study in korea

Conditions: Clostridium Difficile Infection

Summary: our objective of this study is to derive a real incidence of cdi in tertiary hospitals located through korean peninsula. in order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. along with the incidence of cdi, clinical characteristics and outcome of cdi will be examined and microbiologic characteristics of c. difficile isolates from cdi patients are studied.


Eligibility criteria:
inclusion criteria: * aged older than 19 years * more than 3 times of unformed stools passage per day * positive results of toxin gene test: gdh (+) + pcr (+), gdh (+) + toxin (+), or pcr (+) + toxin (+) * agree with informed consent exclusion criteria: * less than 3 times of unformed stool passage per day * use of oral metronidazole or vancomycin more than 24 hours before enrollment * use of laxative before enrollment * recurrent episode of cdi * disagree with study protocol

Keywords: clostridium difficile incidence
efficacy of immediate allogeneic hematopoietic stem cell transplantation versus bridging therapy followed by transplantation in higher-risk myelodysplastic syndrome patients

Conditions: Myelodysplastic Syndromes

Summary: this study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (hsct) is non-inferior to hsct following bridging therapy in patients with higher-risk myelodysplastic syndrome (hr-mds).

this study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (hsct) is non-inferior to hsct following bridging therapy in patients with higher-risk myelodysplastic syndrome (hr-mds).a total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). the study will continue until at least 124 events occur.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. high relapse risk mds, defined by: * ipss-r score ≥3.5. * ipss-m stratification as intermediate-high, high, or very high risk. 3. eligible for allogeneic hsct (including matched or mismatched related/unrelated donor transplantations). 4. karnofsky performance status (kps) ≥60. 5. signed informed consent. exclusion criteria: 1. severe organ dysfunction: * left ventricular ejection fraction \<50%. * oxygen supplementation requirement. * serum bilirubin \>1.5x upper limit of normal (unless due to gilbert syndrome) or ast/alt \>5x upper limit of normal. * estimated glomerular filtration rate (egfr) \<50 ml/min. 2. history of prior allogeneic hsct. 3. any condition deemed unsuitable by the investigator.
exploring the long-term cardiovascular effects of vaping

Conditions: Cardiovascular Diseases

Summary: smoking is the "leading, preventable death-cause worldwide", being responsible for almost 700,000 deaths in the e.u. annually. therefore, implementing successful, long-term smoking cessation strategies is a long-term priority for the nhs. recent evidence suggests that e-cigarettes (i.e., vaping) are a successful cessation tool, with around 3.6 million users in the uk. there are concerns about long-term vaping, particularly in relation to their cardiovascular effects, as there are no relevant, longitudinal studies. therefore, we propose a 38-month, four-group longitudinal study exploring the cardiovascular physiological effects of the use of e-cigarettes over a two-year period, informing policy makers and e-cigarette users (vapers). our study was developed with the support of vapers. the main research question is whether there are any differences in cardiovascular physiology between vapers, who are ex-smokers (group a), vapers with no previous smoking experience (group b), dual users (i.e., those who vape and smoke (group c) and ex-smokers who don't vape (group d). two-hundred participants from sheffield and leeds will be invited on five occasions (baseline, as well as 6-,12-,18- and 24-months post-baseline). we will assess macrovascular and lung function, cardiovascular disease risk (through questionnaires and blood biomarkers), vaping and smoking dependence, smoking and and vaping history among others.


Eligibility criteria:
inclusion criteria: * inclusion criteria: age ≥18 years of either gender. specific group inclusion criteria include: group a: ex-smokers with previous smoking history of at least two years, who vape for at least one year, at least 50 puffs a day. group b: current vapers who have been vaping daily (minimum 50 puffs/day) for at least one year, with no previous smoking history, group c: current vapers (50 puffs/day), who smoke at least 20 cigarettes per week. group d: ex-smokers, who have stopped smoking for a period greater than one year and who currently do not vape. exclusion criteria: * non-ambulant people and people with a recent (e.g., within 6 months) cvd event (e.g. stroke, myocardial infarction) or cardiac surgery, * pregnancy, * people who require major surgery (which will prevent them of taking part in the study), * people who are unable or unwilling to give informed consent.

Keywords: vaping macrocirculation smoking blood biomarkers
mediators of inflammation, prognostic markers and genetic polymorphisms in patients with sepsis

Conditions: Sepsis

Summary: during the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.

primary outcome measures: new diagnostic and prognostic markers for septic patients estimated enrollment: 300 patients study start date: january 2012 estimated study completion date: open estimated primary completion date: open intervention details: procedure: vein puncture comparison of different inflammatory markers in the blood of septic patients

Eligibility criteria:
inclusion criteria: * sirs-criteria * proven infection * one sepsis-induced organ-failure * adults \< 18 years old exclusion criteria: * anemia * pregnancy * blood donor in the last 3 month

Keywords: sepsis inflammation diagnosis prognosis survival mortality
medical management of caries in the primary dentition using silver nitrate

Conditions: Dental Caries

Summary: this pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.

this is a two-arm, parallel group, patient-randomized controlled pilot trial. children with at least one primary tooth where caries extends into dentine. children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention. baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.

Eligibility criteria:
inclusion criteria: * presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp. * absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study exclusion criteria: * hereditary developmental defects of the teeth such as amelogenesis imperfecta and dentinogenesis imperfecta * medical conditions that prevent treatment of the child in the outpatient clinic. these conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team. * known allergy/sensitivity to any of the dental materials.

Keywords: silver nitrate children dental caries medical management quality of life
physiological factors that influence maintenance of lifestyle changes and weight loss - a cross-sectional study

Conditions: Obesity; Overweight

Summary: in denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. one approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. the immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style. the purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention. the investigators have the following research questions: 1. are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss? 2. does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes? 3. how does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss? the study design is cross-sectional and will be based on a lifestyle intervention, as it is practiced in a real life setting at ubberup folk high school. the investigators will recruit former participants of this lifestyle style intervention. 50 % who maintained a weight loss and a healthy life style and 50 % who did not.


Eligibility criteria:
inclusion criteria: * former participants of ubberup folk high school exclusion criteria: * gastric bypass surgery or gastric banding

Keywords: weight loss maintenance body composition physical activity lifestyle intervention
extension study of proellex in women who have previously completed study zpu 003

Conditions: Uterine Fibroids

Summary: zpu-003 ext is a 2-year extension study of zpu-003 (nct00882258) to determine the continued safety and efficacy of proellex in women who have previously completed the double-blind portion of the study.

zpu-003 ext is a 2-year extension study of zpu-003 (nct00882258). the purpose of the study is to determine the continued safety and efficacy of proellex in women who have previously completed the double-blind portion of the study. the desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. the total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). it is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (odi).

Eligibility criteria:
inclusion criteria: * completed the zpu 003 study and met the inclusion/exclusion criteria of that study. exclusion criteria: * low or high grade cervical dysplasia, as determined by papanicolaou (pap) smear. * pregnant or breastfeeding.

Keywords: uterine fibroids
aerobic fitness in overweight and obese individuals

Conditions: Healthy

Summary: oxyjun is known for improving cardiovascular endurance. overweight and obese individuals are at increased risk of cardiovascular complications. to lower the risk, these individuals need to remain physically active with acceptable aerobic fitness. hence, the objective of the study is to investigate the effect of oxyjun on aerobic fitness in physically active overweight and obese individuals. all subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.


Eligibility criteria:
inclusion criteria: * body mass index ≥ 25 - ≤ 34.9 kg/m2. * waist circumference ≥ 80 cms. * non-smoker. * bp ≤ 140/90 mm hg * fbs ≤ 125 mg/dl * hb ≥ 11 g/ dl * can abstain from strenuous exercise and alcohol for at least 48 hours. * can abstain from caffeine for at least 24 hours. exclusion criteria: * participants with history of regular (≥2 times a week) structured exercise (gym, walking, yoga, etc). * inter-arm blood pressure is ≥10 mm hg. * known cases of type ii diabetes mellitus. * known cases of hypertension with or without anti-hypertensive medication. * visual or balance problems, or who cannot walk on a treadmill without using the handrails.
effect of traditional chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is evaluate the effects and safety of traditional chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (copd).

this is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of traditional chinese medicine (tcm) in copd subjects. following a 14 day run-in period, approximately 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. after the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. the primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. fev1). secondary efficacy measures include dyspnea (mmrc), quality of life ( cat,sf-36), exercise capacity( 6mwd). safety will be assessed through the collection of adverse events. there will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). a follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of mild/moderate copd. * age between 40 and 80 years. * syndrome differentiation belongs to syndrome of lung-qi deficiency, syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney. * without participation in other interventional trials in the previous one month. * with the informed consent signed. exclusion criteria: * pregnant or breast-feeding women. * any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study . * complicated with severe heart failure (class ⅳ nyha heart function) or unstable hemodynamics. * complicated with bronchial asthma, bronchiectasis or active tuberculosis； * complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis， * complicated with pneumothorax, pleural effusion or pulmonary embolism. * complicated with neuromuscular disorder which affects the respiration. * complicated with tumors. * complicated with serious hepatic and renal diseases. * long periods of bed rest. * use of oral or parenteral corticosteroids before 1 months of visit 1 . * with immunodeficiency. * participating in other trials or allergic to the used medicine.

Keywords: pulmonary disease, chronic obstructive double-blind method medicine, chinese traditional humans treatment outcome